Patient Preference, Sleep Quality, and Anxiety/Depression: A Randomized Comparison of Etravirine and Efavirenz

Not Applicable

Completed

• Conditions: Sleep Disorders
• Interventions: Drug: efavirenz; Drug: etravirine

• Registration Number: NCT00792584
• Lead Sponsor: University Hospital, Geneva

Brief Summary

Efavirenz causes neuropsychiatric side effects and sleep disturbance, including vivid dreams, dizziness, and abnormal tiredness. These symptoms are frequent during the first weeks of treatment, with subsequent attenuation but may not completely resolve even years after efavirenz initiation.

The investigators plan a twelve week, randomized, placebo-controlled, double-blind study. In group 1, efavirenz will be replaced with efavirenz placebo plus etravirine, in group 2, efavirenz would be continued, and etravirine placebo given in addition. After six weeks, patients in group 1 would switch to the regimen of group 2, and vice versa.

The primary endpoint of the trial will be patient preference. Sleep quality, daytime sleepiness, and anxiety will also be investigated.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Primary Completion: 2008-11
• Study First Submitted: 2008-11-17
• Study First Submitted QC: 2008-11-17
• Study First Posted: 2008-11-18
• Study Completion: 2009-06
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-09
• Last Update Posted: 2011-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Adult patients > 18 years
• Signing the study consent form and agree to change ART regimen
• Stable HAART including EFV since at least 3 months
• HIV-RNA below 50 copies for at least 3 months

Exclusion Criteria

• No major psychiatric disease (psychosis, severe depression) diagnosed before the initiation of EFV

• Mentally incompetent patients

• Pregnancy or lactation Women of childbearing potential must use one or two reliable contraceptive methods during the trial, from day 1 to the end of week 12. Acceptable methods include the birth control pill, IUD, condoms with spermicides. Non-acceptable methods include (non-exhaustive list): Withdrawal, calendar (Onigo method), or spermicides alone.

• Concomitant renal or hepatic disease:

  • Creatinine above 150 micromol/L
  • Transaminases above 5 times upper normal limit
  • Prothrombin (Quick) value below 50%

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	efavirenz	patients treats with efavirenz for 6 weeks
1	etravirine	patients treats with etravirine for 6 weeks

Primary Outcome Measures

Name	Time	Method
Symptoms and neurological side effects of study drugs	baseline, week 6 and week 12

Secondary Outcome Measures

Name	Time	Method
Symptoms of depression, anxiety and stress will be assessed	baseline, week 6 and week 12
Levels of daytime sleepiness	baseline, week 6 and week 12
Sleep Quality	baseline, week 6 and week 12
Patient preference	12 weeks

Trial Locations

Locations (1)

Geneva Hospital; 🇨🇭 Geneva, Switzerland